Surgical drape

ABSTRACT

Disclosed is a surgical drape configured to selectively allow or block a patient&#39;s view of the surgical field, as is desired in Caesarean section operations. Generally, the drape includes a main sheet, a substantially transparent sheet attached to the main sheet proximal the patient&#39;s head, and a substantially opaque screen attached to the patient-facing side of the substantially transparent sheet. This substantially opaque screen occludes the patient&#39;s visual access through the substantially transparent sheet but may be at least partially removed to permit the patient viewing access through the substantially transparent sheet towards the area of the surgery, without compromising the sterility of the surgical field. Desirably, the drape is provided with an adhesive strip disposed on the sheet or screen to permit reconnection to thereby again occlude the patient&#39;s view through the sheet.

TECHNICAL FIELD

This patent relates to a drape for covering a patient during a surgicalprocedure.

BACKGROUND

Currently, a traditional Cesarean section procedure, also known as“C-section,” is most commonly performed with the patient covered by asolid surgical drape. The drape is typically constructed of amulti-layer combination of spunbond and meltblown materials, commonlyreferred to as SMS nonwoven fabric.

Because the mother is typically awake and alert during the C-section, itis desirable to provide a barrier or screen to occlude the mother's viewof the surgical area during the procedure. Many traditional drapes arein a “T” shape, with the top portion of the “T” acting as the anesthesiascreen that obscures the patient's view of the surgical area. The drapeis placed over the patient to isolate a sterile field near the patient'sabdomen. The anesthesia screen is propped up on vertical standards ateach side of the operating table near the patient's head or on acrossbar proximal the head.

In this arrangement, the mother does not have an opportunity to see hernewborn immediately after delivery. It is desirable in the first momentsafter birth for the mother and child to establish an immediateconnection. Because traditional surgical drapes obscure the mother'sview of the newborn in the first moments after delivery, the mother andchild do not have an opportunity to establish this immediate connection.

To address this concern, it is known to provide surgical drapes thatincorporate a coverable window and an opaque flap that can be attachedand detached to alternately obscure and expose the window. It has nowbeen realized that many such known drapes are undesirable in that theyare configured in ways that might allow for contamination of thesurgical field once the flap is removed, particularly if the flap isfolded into the surgical field.

A new surgical drape has now been devised. Generally, the drape includesa main sheet having a first patient-facing side and a secondsurgeon-facing side. The main sheet includes a fenestration throughwhich a surgical procedure may be performed. The main sheet has a headregion that is located near the head of the patient during the surgicalprocedure, and a substantially transparent sheet attached to the mainsheet proximal the head region. The substantially transparent sheetallows the patient visual access to the surgeon-facing side from behindthe substantially transparent sheet. The drape also includes also asubstantially opaque screen attached to the patient-facing side of thesubstantially transparent sheet. This substantially opaque screenoccludes the patient's visual access through the substantiallytransparent sheet when the substantially opaque screen is attached tothe substantially transparent sheet. The substantially opaque screen isat least partially removable from the substantially transparent sheet topermit the patient viewing access through the substantially transparentsheet towards the area of the surgery. In this manner, the patient mayview the birth of the infant or may view the infant immediately afterbirth.

The drape is configured such that the substantially opaque screen may bereattached to the patient side of the substantially transparent sheet toagain occlude the patient's view of the surgical site. In this manner,the surgeon, after having permitted the patient to view the surgicalsite through the substantially transparent sheet, may occlude thepatient's view of the surgical site so that, if desired, the surgeon cancontinue with the procedure with the surgical area again being occluded.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a surgical drape in accordance with oneembodiment of the invention, shown in use positioned over a patient in asurgical bed.

FIG. 2 is a top plan view of the surgical drape shown in FIG. 1.

FIG. 3 is a front perspective view of the surgical drape shown in FIG.1.

FIG. 4 is a rear perspective view, partially cut away, of the surgicaldrape and bed shown in FIG. 1, depicting the substantially opaque screenattached to the substantially transparent sheet.

FIG. 5 is a view similar to FIG. 4 but depicting top edge of thesubstantially opaque screen having been separated from the substantiallytransparent sheet.

FIG. 6 is a rear perspective view of an upper portion of the surgicaldrape as shown in FIGS. 1 and 4, enlarged with respect to FIGS. 1 and 4,and depicting a strip of material that connects the substantially opaquescreen and the substantially transparent sheet.

FIG. 7 is a view similar to FIG. 6 but depicting the substantiallyopaque screen being removed from the substantially transparent sheet.

FIG. 8 is a view similar to FIG. 5 but with the substantially opaquescreen reattached to the substantially transparent sheet.

Reference herein to “top” and bottom” are intended to relate the variousviews to one another and such reference is not intended to limit theorientation of the drape when in use.

DETAILED DESCRIPTION

Referring to FIG. 1, the surgical drape 10 includes a main sheet 11having a center portion 12, first side portion 14, second side portion15, and transverse portion 16. The center portion 12 has a bottom edge17, a top edge 18, and first and second side edges 20 and 21 joining thebottom edge 17 and the top edge 18. The transverse portion 16 isattached to the center portion 12 near the top edge 18 of the centerportion 12. The first side portion 14 is attached along the first sideedge 20 of the center portion 12. The first side portion 14 is alsoattached along a lower edge 22 of the transverse portion 16. Similarly,the second side portion 15 is attached along the second side edge 21 ofthe center portion 12. The second side portion 15 is attached along thelower edge 22 of transverse portion 16.

The main sheet 11 and the transverse portion 16 may be constructed ofany suitable material, and as shown are constructed of a multi-layercombination of spunbond and meltblown materials, commonly referred to asSMS nonwoven fabric. This combination provides a durable and absorbentflexible fluid barrier between the patient and the sterile field thatare soft to the touch. The first and second side portions 14 and 15 aremade of a flexible fluid impervious and non-absorbent material, such aspolyethylene film.

Referring to FIGS. 2 and 3, the surgical drape 10 also includes asubstantially transparent sheet 24. A bottom edge 25 of thesubstantially transparent sheet 24 is attached along a top edge 26 ofthe transverse portion 16. The length of transverse portion 16 extendsthe width of the surgical drape 10. The substantially transparent sheet24 may be made of any suitable material, such as polyethylene film.Further, as seen, the substantially transparent sheet extends across theentire surgical drape transverse width of the surgical drape.

The main sheet 11 includes a fenestration 42 through which a surgeryaccessing a patient's body may be performed. The fenestration 42 is anopening formed in the material of main sheet 11 sized according to theparticular procedure for which the surgical drape 10 is to be used. Inone embodiment, fenestration 42 is sized to allow sufficient access to apatient's abdominal region to perform a C-section procedure.Fenestration 42 is covered with a flexible adhesive film 44 known in theindustry as “incise film,” which may be formed from polyurethane oranother suitable material to form a “full incise” fenestration. When thesurgical drape 10 is laid over a patient, the flexible adhesive film 44is first covered with a removable backing 49. Before the procedure isperformed and after the surgical drape 10 is laid over the patient, theremovable backing is removed from the flexible adhesive film 44,exposing the adhesive bottom surface of the flexible adhesive film 44.The flexible adhesive film 44 adheres to the skin of the patient. Whenthe procedure is performed, incisions may be made directly through theflexible adhesive film 44.

As illustrated, flexible adhesive film 44 is a full panel film thatcovers the entirety of fenestration 42. It is contemplated that a“fenestrated incise” structure (not shown) alternatively may beemployed, wherein there is adhesive disposed around the perimeter of thefenestration. This leaves an opening in a center portion of the flexibleadhesive film through which the patient's skin is exposed to permitincisions to be made directly though the exposed skin.

With further reference to FIG. 2, the fenestration 42 may besubstantially surrounded by a fluid collection pouch 45. The fluidcollection pouch 45 is made of a plastic material impervious to fluid.The fluid collection pouch 45 surrounds the fenestration 42 in a sealingfashion such that any fluids released from the surgical site during theprocedure will run off the sheet into fluid collection pouch 45. Thisprevents fluids from running off the main sheet 11 and onto the floor orother areas where fluids are not desired. The fluid collection pouch 45may include one or more suction ports 46 for connection to suctionequipment for aspirating the fluids from the fluid collection pouch.

The fluid collection pouch 45 includes an opening 47 through which thesurgeon may access fenestration 42. The edges of the opening 48 may bebound by a formable material 50, such as a malleable wire encased inplastic. The formable material 50 allows the surgeon to shape theopening of fluid collection pouch 45 to allow for easier access tofenestration 42 or to reconfigure the shape of fluid collection pouch 45in a manner that is most effective for the particular procedure.

The main sheet 11 includes one or more line anchors 51 for securingwires or lines to the surgical drape 10. The line anchors 51 consist oftwo plies of hook and loop material that may be separated at one end,but which are attached at another end. When the plies of the hook andloop material are separated, a line may be inserted between the twoplies and when the plies are joined again, the hook and loop materialcaptures the line between the two plies of material.

The main sheet 11 also includes an absorbent pad 52, which, as shown, isconfigured as a separate pad disposed on the main sheet 11. Absorbentpad 52 is located near fenestration 42 and is made up of a materialsuitable for absorbing fluids generated during the surgical procedure.The absorbent pad 52 provides another measure of fluid retention in theinstance where fluids are not collected by the fluid collection pouch45.

As supplied, the surgical drape 10 is initially provided in a sterilefolded state wrapped in a sterile fabric wrapper (not shown) and anouter package (also not shown), as is conventional. The sterile fabricwrapper surrounds the surgical drape 10 to protect the surgical drape 10and maintain its sterile state. The surgical drape 10 wrapped in thesterile fabric wrapper is enclosed in a plastic pouch. The plastic pouchfurther protects the surgical drape 10 and maintains its sterilecondition.

Referring to FIGS. 3 and 4, a bottom edge 27 of a substantially opaquescreen 28 is attached to the patient-facing side of the transverseportion 16 sufficiently to preclude the patient from viewing thesurgical field beneath the screen. Preferably the screen is attachedbelow the point at which the bottom edge 25 of the substantiallytransparent sheet 24 is attached to the top edge 26 of the transverseportion 16. The substantially opaque screen 28 may be made of anysuitable material, such as SMS non-woven fabric. A top edge 30 of thesubstantially opaque screen 28 is attached proximate its outer edges tothe patient-facing side of substantially opaque screen 28 proximal a topedge 31 of the substantially transparent sheet 28. The attachment ismade via first and second adhesive tape strips 32 and 34 discussed inmore detail below.

Referring to FIG. 6, the top edge 30 of the substantially opaque screen28 is attached to the patent-facing side of the transparent sheet 24 viathe first and second adhesive tape strips 32 and 34. First and secondadhesive tape strips 32 and 34 include first regions, 35, 35′respectively, attached to the patient-facing side of the substantiallytransparent sheet 24. The strips include a second region 36, 36′respectively attached along the top edge 30 of the substantially opaquescreen 28. The first and second regions of each adhesive tape strip areconnected to one another along a demarcated line of weakness, such asstrip scoreline 37, 37′ that partially scores the first and secondadhesive tape strips 32 and 34. The strip scorelines 37, 37′ isgenerally formed by severing the first and second adhesive tape strips32 and 34 along their lengths partially through their thickness suchthat a separated area is formed above the bridging area between thefirst region and the second region of each strip. In this embodiment,the strip scorelines 37, 37′ are generally centrally positioned alongthe width of the first and second adhesive tape strips 32 and 34.

Thus, based at least in part on the relatively small thickness of thebridging area, the first region 35, 35′ can be separated from the secondregion 36, 36′ via manual tearing. Referring to FIG. 7, to detach thesubstantially transparent sheet 24 from the substantially opaque screen28 a user may manually separate the first and second regions 35 and 36of first and second adhesive tape strips 32 and 34. When the first andsecond regions 35 and 36 are severed along scoreline 37, the firstregion 35 remains attached to the patient-facing side of substantiallytransparent sheet 24. The second region 36 remains attached to thepatient-facing side of substantially opaque screen 28. In this manner,the top edge 30 of the substantially opaque screen 28 is separated fromthe substantially transparent sheet 24. In this manner, thesubstantially opaque screen 28 may be detached and lowered to permit thepatient to view the surgical area, as illustrated in FIG. 5.

Referring again to FIGS. 6 and 7, a first refastening strip 38 and asecond refastening strip 40 are connected along the top edge 30 of thesubstantially opaque screen 28 on a side of the substantially opaquescreen 28 proximal the first and second adhesive tape strips 32 and 34.First and second refastening strips 38 and 40 have two sides, both ofwhich are covered by an adhesive. One side of each of the first andsecond refastening strips 38 and 40 is adhered to the substantiallyopaque screen 28. The other side of each of the refastening strips 38and 40 is covered by a removable backing 41. The removable backing 41may be removed to expose the adhesive material. Once the removablebacking 41 is removed and the adhesive is exposed, the first and secondrefastening strips 38 and 40 may be used to re-adhere the substantiallyopaque screen 28 to the substantially transparent sheet 24 by pressingthe exposed adhesive on refastening strips 38 and 40 to thepatient-facing side of the substantially transparent sheet 24. Via thesestrips, after the patient views the surgical area, the substantiallyopaque screen 28 may be reattached to the substantially transparentsheet 24, as shown in FIG. 8.

As illustrated, the strips are disposed at the top of the screen, butother configurations are possible. For instance, the strips may bedisposed at a different location on the screen, or may be provided onthe substantially transparent sheet. Similarly, the sheet and screen areshown as being substantially rectilinear in configuration, but othershapes are possible, as is also possible for the main sheet. As analternative to the adhesive strip, or in addition thereto, otherimplementations may be provided for refastening the substantiallytransparent sheet to the screen, these including, for instance,hook-and-loop material, ties, buttons, or other suitable fasteners. Suchfasteners can be positioned in any manner suitable to effectuaterefastening.

In using the surgical drape 10, the patient is first laid on a surgicaltable. Once the patient is in position on the surgical table, thesurgical drape 10 is removed from the plastic pouch. At this point, thesurgical drape 10 is enclosed within the sterile wrapper. A member ofthe surgical team may remove the wrapped surgical drape 10 from thecontainer, and, by using methods known in the field, may unwrap thesurgical drape 10 and present it to a member of the surgical team thathas performed personal decontamination, such that the sterile state ofthe surgical drape 10 may be maintained during setup of the surgicalprocedure. After the surgical drape 10 is removed from the sterilewrapper, it is unfolded, and as it is unfolded it is lain over thepatient. As it is unfolded and lain over the patient, when the portionof fenestration 42 is positioned over the surgical site of the patient,the removable adhesive backing is removed from the incise film 44, andthe incise film 44 is adhered to the patient's skin and the site of thesurgical area. The outer portions of substantially transparent sheet 24are attached using spring clamps or other attaching means to N poles, orother standards used in operating rooms for positioning surgical drapes.The substantially transparent sheet 24 attached to the poles separatesthe patient's head from the sterile field. At this point in theprocedure, the substantially opaque screen 28 remains attached tosubstantially transparent sheet 24 to occlude the view of the patientthrough the substantially transparent sheet 24, as seen in FIG. 4.

The surgical procedure may then proceed, and at a time at which thesurgeon wishes to allow the patient to view an area around the surgicalsite, the substantially opaque screen 28 may be partially detached fromsubstantially transparent sheet 24 to allow the patient to view thesurgical area, as illustrated in FIG. 5. In the case of a C-section,this allows the new mother to view the newborn baby immediately afterthe baby is removed in the C-section procedure. After the mother has hadan opportunity to view the baby, a member of the surgical team mayreattach the substantially opaque screen 28 to the substantiallytransparent sheet 24 using the first and second refastening strips 38and 40. The remainder of the surgical procedure may then be performedwith the patient's vision in direction towards the surgical sceneoccluded.

It is thus seen that a drape that allows the surgeon to selectivelypermit the patient to view the area near the surgical field is provided.In a C-section procedure, the patient may or may not be able to view theactual surgical field, so long as she has a view through thesubstantially transparent sheet towards the surgeon-facing side of thedrape. Notably, because the substantially opaque screen 28 remainsoutside of the sterile field, the risk of contamination is reduced evenwhere the screen is removed and re-attached. The surgical drape 10 isparticularly suitable for C-section procedures, but it is contemplatedthat the surgical drape 10 will find other surgical uses.

Uses of singular terms such as “a,” “an,” are intended to cover both thesingular and the plural, unless otherwise indicated herein or clearlycontradicted by context. The terms “comprising,” “having,” “including,”and “containing” are to be construed as open-ended terms. Anydescription of certain embodiments as “preferred” embodiments, and otherrecitation of embodiments, features, or ranges as being preferred, orsuggestion that such are preferred, is not deemed to be limiting. Theinvention is deemed to encompass embodiments that are presently deemedto be less preferred and that may be described herein as such. Allmethods described herein can be performed in any suitable order unlessotherwise indicated herein or otherwise clearly contradicted by context.The use of any and all examples, or exemplary language (e.g., “such as”)provided herein, is intended to illuminate the invention and does notpose a limitation on the scope of the invention. Any statement herein asto the nature or benefits of the invention or of the preferredembodiments is not intended to be limiting. This invention includes allmodifications and equivalents of the subject matter recited herein aspermitted by applicable law. Moreover, any combination of theabove-described elements in all possible variations thereof isencompassed by the invention unless otherwise indicated herein orotherwise clearly contradicted by context. The description herein of anyreference or patent, even if identified as “prior,” is not intended toconstitute a concession that such reference or patent is available asprior art against the present invention. No unclaimed language should bedeemed to limit the invention in scope. Any statements or suggestionsherein that certain features constitute a component of the claimedinvention are not intended to be limiting unless reflected in theappended claims. Neither the marking of the patent number on any productnor the identification of the patent number in connection with anyservice should be deemed a representation that all embodiments describedherein are incorporated into such product or service.

The invention claimed is:
 1. A surgical drape comprising: a mainsheethaving a mainsheet transverse width at a head region for placementproximal a head of a patient during a surgical procedure, the mainsheethaving a fenestration therein permitting access to a surgical region forperformance of the surgical procedure when the drape covers the patientduring the surgical procedure, and having a surgeon-facing side and apatient facing side; a substantially transparent sheet having asurgeon-facing side and a patient-facing side, the substantiallytransparent sheet having a transverse width substantially equal to themainsheet transverse width and connected to the mainsheet at aconnecting location, said connecting location being adjacent said headregion and providing the patient with visual access therethrough; and asubstantially rectilinear, substantially opaque screen attached to thepatient-facing side of the substantially transparent sheet and effectiveto occlude the patient's visual access through the substantiallytransparent sheet at the substantially opaque screen, said substantiallyopaque screen covering a portion of the substantially transparent sheet,the portion of the substantially tranparent sheet being less than atotal surface area of the substantially transparent sheet, thesubstantially opaque screen attached below the connecting location, saidsubstantially opaque screen being at least partially removable from saidsubstantially transparent sheet to thereby permit the patient's visualaccess through the substantially transparent sheet, the substantiallyopaque screen having top and bottom boundaries, the substantially opaquescreen being removably attached to the patient-facing side of thesubstantially transparent sheet proximal the top boundary of thesubstantially opaque screen, further comprising a fluid collection pouchat least partially surrounding said fenestration.
 2. The surgical drapeof claim 1, the head region defining a top edge of the mainsheet.
 3. Thesurgical drape of claim 1, the substantially opaque screen beingreconnectable to the patient-facing side of the substantiallytransparent sheet after the substantially opaque screen has been atleast partially removed from said substantially transparent sheetwherein upon reconnection the substantially opaque screen is againeffective to occlude the patient's visual access through thesubstantially transparent sheet.
 4. The surgical drape of claim 3, thedrape being provided with an adhesive strip, the adhesive strip beingcovered with a removable covering material, the adhesive strippermitting reconnection of the substantially opaque screen to thepatient-facing side of the substantially transparent sheet upon removalof the removable covering material.
 5. The surgical drape of claim 1,the drape comprising a strip of material connecting the substantiallytransparent sheet to the substantially opaque screen, the strip ofmaterial having a demarcated line of weakness connecting first andsecond regions of the strip of material, the first region of the stripof material connected to the substantially transparent sheet and thesecond region of the strip of material connected to the substantiallyopaque screen.
 6. A method, comprising: applying the surgical drape ofclaim 1 to a patient; at least partially disconnecting a substantiallyopaque screen portion of the surgical drape to allow the patient visualaccess to an area proximal a surgical region through the substantiallytransparent sheet of the surgical drape; and reconnecting the at leastpartially disconnected substantially opaque screen portion of thesurgical drape to the patient-facing side of the substantiallytransparent sheet to occlude the patient's visual access to an areaproximal a surgical region.
 7. The method of claim 6, where thepartially disconnected substantially opaque screen portion isreconnected to the patient-facing side of the substantially transparentsheet by an adhesive strip.
 8. The method of claim 6, where thesubstantially opaque screen is disconnected from the substantiallytransparent sheet by severing a strip of material connecting thesubstantially transparent sheet to the substantially opaque screen alonga demarcated line of weakness connecting first and second regions of thestrip of material, the first region of the strip of material connectedto the substantially transparent sheet and the second region of thestrip of material connected to the substantially opaque screen.
 9. Thesurgical drape of claim 4, the drape being provided with at least oneadhesive tape strip, the tape strip having a first region and a secondregion connected to one another along a demarcated line of weakness. 10.A surgical drape comprising: a mainsheet having a fenestration thereinpermitting access to a surgical region for performance of a surgicalprocedure when the drape covers a patient during the surgical procedure,the mainsheet having a head region for placement proximal the head ofthe patient during the surgical procedure and having a surgeon-facingside and a patient-facing side; a substantially transparent sheet havinga surgeon-facing side and a patient-facing side and joined to themainsheet at said head region for providing the patient with visualaccess therethrough; and a substantially opaque screen attached to thepatient-facing side of the substantially transparent sheet and effectiveto occlude the patient's visual access through the substantiallytransparent sheet, said substantially opaque screen being at leastpartially removable from said substantially transparent sheet to therebypermit the patient's visual access through the substantially transparentsheet, wherein the substantially transparent sheet has a first totalsurface area and the substantially opaque screen has a second totalsurface area that is less than the first total surface area of thesubstantially transparent sheet.
 11. The surgical drape of claim 10wherein the mainsheet has a mainsheet transverse width at a terminaledge adjacent the head region, and wherein the substantially transparentsheet has a transverse width substantially equal to the mainsheettransverse width.
 12. The surgical drape of claim 10 wherein thesubstantially opaque screen has a screen transverse width that is lessthan a transverse width of the substantially transparent sheet.
 13. Thesurgical drape of claim 10 wherein the substantially opaque screen has ascreen height that is less than a height of the substantiallytransparent sheet.
 14. A surgical drape comprising: a mainsheet having amainsheet transverse width at a head region for placement proximal ahead of a patient during a surgical procedure, the mainsheet having afenestration therein permitting access to a surgical region forperformance of the surgical procedure when the drape covers the patientduring the surgical procedure, and having a surgeon-facing side and apatient-facing side; a substantially transparent sheet having asurgeon-facing side and a patient-facing side and having a transversewidth substantially equal to the mainsheet transverse width, thesubstantially transparent sheet connected to the mainsheet at said headregion for providing the patient with visual access therethrough; and asubstantially opaque screen attached to the patient-facing side of thesubstantially transparent sheet and effective to occlude the patient'svisual access through the substantially transparent sheet, saidsubstantially opaque screen being at least partially removable from saidsubstantially transparent sheet to thereby permit the patient's visualaccess through the substantially transparent sheet, wherein thesubstantially transparent sheet has a first total surface area and thesubstantially opaque screen has a second total surface area that is lessthan the first total surface area of the substantially transparentsheet.
 15. The surgical drape of claim 14 wherein the substantiallyopaque screen has a screen transverse width that is less than atransverse width of the substantially transparent sheet.
 16. Thesurgical drape of claim 14 wherein the substantially opaque screen has ascreen height that is less than a height of the substantiallytransparent sheet.